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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, spot-film
Regulation Description Spot-film device.
Product CodeIXL
Regulation Number 892.1670
Device Class 2


Premarket Reviews
ManufacturerDecision
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 3
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 1 1 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Philips Medical Systems North America Co. Phillips II Mar-08-2011
2 Philips Medical Systems North America Co. Phillips II Sep-13-2010

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